ProtecTINT 52N
- Product NDC
- 75936-635
- 11-digit product format
- 759360635
- Labeler code
- 75936
- Product ID
- 75936-635_40975baf-b82b-0621-e063-6294a90a217d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octisalate, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Supergoop, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-11-22
- Substance
- HOMOSALATE; ZINC OXIDE; OCTISALATE
- Active strength
- 7; 13.58; 5 g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 75936-635-02 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 75936-635-02 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 75936-635-02 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 75936-635-02 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 75936-635-02 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 75936-635-02 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 75936-635-02 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 75936-635-02 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ProtecTINT 52N
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HOMOSALATE | 7 g/100mL |
| ZINC OXIDE | 13.58 g/100mL |
| OCTISALATE | 5 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0801287f-0df5-4303-e063-6394a90a503b | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75936-635-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9571-d83d-e063-dadaa90ab31f | Protec(tint) SPF 50 |
| 75936-635-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9571-d83d-e063-dadaa90ab31f | Protec(tint) SPF 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75936-635-01 | ProtecTINT 52N | 35 mL in 1 TUBE | CREAM | 35 | 2 | |
| 75936-635-02 | ProtecTINT 52N | 1 in 1 BOX | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75936-635 | PROTECTINT 20C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 26W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 32N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 34C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 58W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 10N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 24N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 22W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 30W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 46N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 42C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 52N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 14N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 40W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [SUPERGOOP, LLC] | 1 | Current NDC, 2 package rows | 20231129_0801287f-0df5-4303-e063-6394a90a503b.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PHYSICAL TINTED MOISTURIZER SPF44 | ZINC OXIDE, TITANIUM DIOXIDE | Drmtlgy, LLC | 483d0d28-56f3-4b37-af03-0331e1653d73 | 2025-11-06 | Warnings | M020 |
| Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 Day | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | d3ebe2a9-434e-497c-8fed-b5c73c70a58b | 2025-11-05 | Warnings | M020 |
| Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | a57bcf44-580d-520e-e053-2a95a90a6923 | 2025-11-05 | Warnings | M020 |
| Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | 865057ce-f617-4232-a60e-e23c120b0a73 | 2025-11-05 | Warnings | M020 |
| Revitalize Solar Protection Fluid Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | 29b3ee35-e849-4427-a455-37d92c4b995c | 2025-11-05 | Warnings | M020 |
| Sarah Creal Brilliant Repair Shield | ZINC OXIDE | Sarah Creal LLC | 258ab6f2-f1a7-2d0d-e063-6294a90af34a | 2025-11-05 | Warnings | M020 |
| Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25 | TITANIUM DIOXIDE | THG Beauty USA LLC | 23a55301-2277-6e4f-e063-6394a90af171 | 2025-11-05 | Warnings | M020 |
| Sun Bum Face and Body Stick 40 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 20d9d60d-e0ce-a177-e063-6394a90a162e | 2025-11-05 | Warnings | M020 |
| Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening System | TITANIUM DIOXIDE, ZINC OXIDE | Obagi Cosmeceuticals LLC | 4cbf1dc6-78b3-4e51-a53f-2018ac88136a | 2025-11-04 | Warnings | M020 |
| SUNBEAT PROCARE FPS 50 KIDS | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLE | Tecnoglobal, PH7 S.A. DE C.V. | 42c74ddf-70a3-f2b1-e063-6294a90a91a9 | 2025-11-04 | Warnings | M020 |
| Vertra Pearl White Face Stick SPF 50 | PADIMATE O, TITANIUM DIOXIDE | Toshiki Pigment Co., ltd. | b7163861-7084-5adf-e053-2995a90ae199 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 8 | OCTINOXATE AND OXYBENZONE | Tropical Seas, Inc. | b5fa2883-998f-2128-e053-2995a90a5c84 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b557c9c5-6ea8-1d59-e053-2995a90aff68 | 2025-11-04 | Warnings | M020 |
| Vertra Ehukai Beige Face Stick SPF 38 | TITANIUM DIOXIDE | Toshiki Pigment Co., ltd. | b71619c4-a8ef-1dda-e053-2995a90aba50 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 45 | OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE | Tropical Seas, Inc. | b4cafdf1-44e1-10c0-e053-2995a90ab3dc | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | e226b07a-9f44-4b17-8f26-c86dcfa5dcda | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b4cc95f0-d684-5331-e053-2995a90a3295 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 20 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b55792e6-2ead-1fb1-e053-2995a90ac915 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 8 | OCTINOXATE AND OXYBENZONE | Tropical Seas, Inc. | b5e68448-4131-1c6c-e053-2a95a90a014a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 40 | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d204c38c-b5d1-3511-e053-2a95a90a9dc8 | 2025-11-04 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75936-635-01 | 75936063501 | 35 mL in 1 TUBE | 35 ml | Historical | |||
| 75936-635-02 | 75936063502 | 1 TUBE in 1 BOX (75936-635-02) / 35 mL in 1 TUBE (75936-635-01) | 1 tube | 2023-11-22 | No | No | Current |